Excited to welcome everyone to our conference. I'm joined today with Juan José and with Raj from Establishment Labs, and, we're excited to get going. We'll jump right in. Juan José, do you wanna tell us about your background, and what opportunity did you see when you founded the company in 2004?
Yes, good morning, and thank you for that question. I think it's very interesting how I think the whole situation evolved for me because I come from a family of plastic surgeons, and, you know, we're very involved in the family business from a young age. I eventually was trained as an economist, but then I came back, and I started running my family's clinic in plastic surgery. So that gave me a big perspective on what was going on at the patient level with, you know, the patients undergoing breast aesthetics for breast reconstruction. Eventually, I started a company distributing plastic surgery products, and for several years, I distributed different types of brands of breast implants, and I came very close to understanding that there was gonna be no innovation in the industry.
And that's when I decided in 2004 that, you know, Establishment Labs could change that. And, you know, the founding principle was that, you know, what this industry lacked was a commitment to women's health, and that's what we brought in with, Establishment Labs, and we did that through science, you know, the power of engineering, and eventually, that led to all the innovations that you see in the market today.
Great. Maybe we can just kinda double-click on that. How specifically are your products and technologies differentiated from competitors?
I think they're based on this principle of bench to bedside. You know, this idea that you can purposely design technology with, you know, a downstream effect that you'll see eventually in patients and hopefully improve their lives. And if you think about something as simple as surface technology, surface technology is something that we completely transformed in our industry. It was this idea that you had, you know, smooth implants and textured implants, but there was no conversation around biocompatibility. So we designed a surface so that at the cell level, you would basically be able to reduce the inflammation, and that would lead to less fibrosis, less capsular contracture, and eventually less of the other problems that we see that are related to inflammation, like, you know, anaplastic large cell lymphomas, squamous cell carcinoma, and other type of B-cell lymphomas.
And that was done, you know, in the lab early on, and now, you know, years later, what we see downstream is that, you know, the rate of complications related to that has never been seen before, and that's the type of things that we do. And we do that not only on the safety side, we also do it on things that are important to patients. You know, most patients in this industry are, you know, elective. Even in breast reconstruction, you know, women elect not to have a breast reconstruction based on problems related to safety, but also on the aesthetic outcomes. So we've done a lot of things on the aesthetic outcome side, you know, with regards to creating the first ergonomic implant in the world.
So, you know, ergonomic as in comfortable because you're wearing these things every day, so you wanna make them comfortable. And, and what we recently brought to market with minimally invasive, I think has the same transformational effect.
Great. How do you specifically approach educating surgeons and patients about kind of the differentiated parts of your products?
I think it changes from market to market because the compliance rules are very different. But if you take the surgeon side, you know, in the international market, most of the education is about how to transition from the traditional texture devices, which was what most plastic surgeons in the international market were using, to, you know, smooth-like devices like ours. And that takes time. You know, a lot of these surgeons have used these texture devices for a very long time, so you have to, like, basically reteach them. And the scientific societies for a long time were not doing that, so we had to take, you know, like, basically the task of doing this. In certain countries, we can go faster with that because surgeons are more open to education.
In some markets, like, you know, for instance, Brazil, where they're very committed to texture devices, it takes longer. On the patient side, I think it's one of the most interesting things because our story has always been, you know, one story in which patients get very involved. If you look at, you know, our social media handles, you know, the amount of engagement that we have with potential patients is very interesting. And, you know, what that creates eventually is that patients are asking plastic surgeons about our technology. In many markets, we cannot do an effective communication directly with consumers, but, you know, for instance, in the U.S., is one of the things that we will be able to do, and that usually gives us speed.
you know, when you look at our market share data, usually the best market share data that we have are in countries where we can communicate more effectively with patients.
Great. Maybe building on the market share point, what can you share with us about the market in terms of relative penetration, the dynamics, what's driving growth in the aesthetics market today?
Yeah, I think I'll let Raj go through, like, some of the percentages and the size of the market, but what I would say is that, you know, what we've been able to prove is that, you know, a non-commodity product and what used to be a commodity market, you know, can thrive, and we've done that at different price points. You know, we have this view that there's a consumer for different price points in breast aesthetics, for instance. And, you know, our job is to bring with the same level of safety, different type of, you know, aesthetic benefits, and we price, we price those. You know, we just launched our JoyDot, you know, program, just, you know, in the last month.
And what JoyDot does is allow us to use our latest technology, Ergonomix, to, for what it is, a super minimal incision, which provides for a, you know, smaller scar, and women love that. So eventually, it's not only about the number of procedures, but, you know, the price that we can extract from each one of those procedures. And what we are doing with innovation is basically add to that. And maybe, Raj, you can talk about, like, the, you know, size of market and market share.
Sure. Yeah, I think, you know, if you look at the global market for our technologies, it's estimated to be between $2 billion and $2.2 billion, something in that range. You know, most markets we go into, as Juan José noted, we strive to be market share leaders, and in most markets, we are between 25% and 50%, some even higher than that. And so, you know, if you think about the next couple of years, we've now entered China earlier this year, the second-largest market in the world. We're going into the United States, hopefully very soon, the largest market in the world. And so we are on the cusp now, I think, of essentially penetrating the entire market and then pushing towards those types of market shares, which, again, we've already achieved in most of the markets we've gone into.
Great. And maybe anything else you want to add in terms of how you're thinking about geography specifically? So in terms of, you know, China's an important market. Any other markets you want to highlight?
Well, I think China is definitely one of the most interesting things that we are doing this year. China has the most dynamic growing market in breast aesthetics. It kind of, like, had this big dip during the pandemic, but it's coming back, and we expect it to be back at pre-pandemic levels by next year. And the other part of the Chinese market that is very interesting is that it's a market in which women really value the quality of the products. And you know, they're willing to make the effort that is necessary, not only on the financial side, but also taking the time off to be able to have these procedures.
And because they have this view that, you know, this is almost like a luxury treatment, then, you know, they command some of the highest ASPs in the world, and that's usually surprising. Definitely, the U.S. is, you know, by far the biggest market right now, and one in which, you know, we, you know, will strive to become market leaders, as quickly as possible because our technology has a differentiation, and it's very well adapted to this market. But beyond, you know, the geographical expansion, there are the things that we are doing to transform breast aesthetics and also breast reconstruction. In breast aesthetics, we have our minimally invasive program, which I think is, you know, so interesting in so many different ways, on the, you know, on how we can attract new consumers to breast aesthetics.
In the, you know, breast reconstruction side, I think, you know, we're changing the way that breast reconstruction is defined, and with that, I think bringing more women into breast reconstruction is one of our big tasks.
Great. And so maybe shifting gears a little bit, you know, huge congrats on the announcement last week with the FDA announcing that the PMA for Motiva Implants is approvable, pending inspection. Maybe you can share with us a little bit, just an update, what are the kind of last steps for the approval process, and when do you expect launch in the U.S.?
Yeah. I'll take the opportunity to talk about one of the things that you know, might be missing from that conversation, and that is that, you know, in the normal cadence, you know, we would have had the inspection, and after the inspection, we would have had a period of 3-6 months in which we would be, you know, basically finalizing the discussions around the clinical data so we can finish the labeling, and also a discussion around post-market studies. Now that we were able to close that before the inspection, it completely takes away that period of time, and I think that's one of the most exciting things about what just happened, and it is important to, you know, to really point that out. For the inspection, you know, we're absolutely ready.
Our team, you know, has had so many different inspections over the last 14 years by high vigilance authorities. So, you know, once they get down to our facilities in Costa Rica, we will have the inspection, which, you know, takes place over several days. At the end, you have basically an in-person meeting in which they report to you any non-conformities, and you address them so that, you know, it becomes acceptable for the agency to allow us commercial activities. So there's some paperwork that will go in there, but we're literally in the last step.
Awesome. And what about, you know, specifically on the commercial preparations and the commercial organization? So we saw the recent hire of Jeff Ehrhardt. Anything else you can share with us about the commercial team?
Yeah, I think it's important to say that, you know, we've been preparing for quite some time, so all of our commercial operations are ready. We're actually currently shipping and invoicing our Flora tissue expander to several hospitals in the U.S. So we've been testing our systems, our logistics, all of that is in place, and now we're, you know, with Jeff, I think we have a phenomenal, you know, head of North America. He's got so much experience. He used to lead plastic surgery for Allergan Aesthetics. He was there for 25 years, so he brings so much in terms of the relationships with the plastic surgeons, and he's building the team. So, you know, Ann Pugh is going to be our head of sales.
Again, someone with a lot of, you know, experience from the industry and knowledge of the U.S., plastic surgery community. And, you know, as we add more sales reps, we, we already had sales reps for the Flora tissue expander, I think, you know, what you're gonna see is that, you know, we're matching as closely as possible, you know, what we are doing in terms of the regulatory path and the commercial path. And I think we're gonna be in a really good place. You know, these recent announcements on the regulatory side, you know, that are de-risking our, our approval, allow us to be a little bit more, aggressive in the, pace of hiring in the U.S.
... Great. What about some of the next generation products like Mia and their timing for entering the U.S. market?
I think, you know, it's interesting, you know, in the very few opportunities that we've had to speak to U.S. plastic surgeons at some conferences that we've been invited to, it's interesting to see how about half of the questions come, you know, that come to us are about Mia. I think it's so exciting, and the plastic surgeons, they see it. They see that minimally invasive can transform breast aesthetics. You know, when we talk to them, they say, "Look, I, I, I love this idea of Motiva, but, you know, I wanna have access to Mia." So we're, you know, we're very committed to to bringing Mia to the U.S. Mia is part of a platform called Ergonomix 2. That's our second generation Ergonomix technology.
With the approval as a supplement, hopefully, of Ergonomix 2, you know, we would be able to unlock two programs, Joy and also Mia. You know, our regulatory experts believe this is something that would take around 18-24 months, but we haven't had that, you know, conversation directly with the agency. I think that's gonna happen shortly after we receive approval. You know, we've been really focusing all of our airtime on the current approval. But, you know, with that, we will have all the necessary information, and we'll be able to be more precise on the timing.
Great. You kinda touched on it, but anything else you would add in terms of specific feedback from plastic surgeons when you talk to them about what Mia is bringing to the market? And what do you think surgeons are really looking for with what they have available today and what Mia can offer?
Yeah, I think, you know, there's something very interesting. There's, you know, first, a lot of curiosity from plastic surgeons because, of course, they've seen their peers in other surgical specialties go, you know, sometimes all minimally invasive. So when you think about breast aesthetics and breast reconstruction, there've been some attempts to go minimally invasive, but they've been very complicated. Like, you know, when you try to do endoscopic breast aesthetics, it requires a lot of equipment. It actually lengthens the time of the procedure. You're still under general anesthesia. There are so, you know, many things that are not part of a better experience for both surgeon and patient, and Mia cuts right through all of that.
You know, of course, there can be some healthy skepticism from some plastic surgeons, you know, like, "How do you, how do you achieve this in just 15 minutes?" You know, "How can you get rid of general anesthesia?" There are all these very interesting things, but the feedback from the, you know, from the plastic surgeons that are now part of this network of Mia Clinics is just an amazing thing. It's just that, you know, it is transforming their practice. Just the fact that they are speaking to their patients during the procedure is, is something they've never done before. So I think, with time and as, you know, the awareness about Mia goes wider, both in plastic surgery circles and also in the awareness from consumers, I think we'll see more of a push towards minimally invasive.
Great. And I think, you know, when we think about the breast reconstructive market, I think a lot of people don't realize how big that is. What can you share with us just about, you know, breast reconstruction is 25% of the global market today. It's a larger share of the U.S. market. How are you targeting that market specifically? And beyond the tissue expander, what are the other products that could be used in reconstruction?
We're totally committed to the transformation of breast reconstruction. We think there are many opportunities there. It's interesting that you say, like, you know, in the U.S., the size of the market for breast reconstruction is higher in terms of total share than the rest of the world, and that is because in the rest of the world, the percentage of women that have access to breast reconstruction is so much lower. In many countries, we're talking single digits, and then when you go to, you know, more advanced societies, like, you know, in Europe, it actually doesn't go up to more than 50%. So there's still a lot of work to be done.
Even in countries where you have access, guaranteed by the public health system, a lot of women elect not to have breast reconstruction because they don't agree with the quality of the results. So what that tells you is that outside of the United States, there's this huge opportunity to grow breast reconstruction, and that's what we are doing with our concept called Aesthetic Breast Recon. And what Aesthetic Breast Recon does is, you know, using technologies just like Flora and some other technologies that we have been working on, then you can actually make breast reconstruction easier to perform by the reconstructive surgeons, but also make it more accessible in terms of, you know, how you can scale it, but also, you know, the cost that it can have for the public health system. So this is something we are working on.
Raj, maybe you can comment on the US.
Yeah, I mean, well, the size of the U.S. market, you know, there's roughly 100,000 implant-based reconstructions, and those use a tissue expander, which, you know, you can think about fifteen hundred, seventeen hundred dollars, kind of the price point for those. You're talking about a market just for tissue expanders, which is $150 million-$170 million. And then there are implants used in those procedures that are about that same size, about 1.7 procedures, excuse me, implants per procedure, which, given the ASPs in that market, you know, it's about another $170 million or so. So right there, you're talking about a market that is, you know, approaching $300 million just in breast reconstruction.
So again, the, you know, the opportunity is there, and certainly with Flora now, which we've launched in the United States, and the benefits of that technology versus anything else available on the market is just profound, and we're seeing, you know, really strong interest in that and traction with that product.
Great. And maybe, Raj, we can spend a minute on financials. How is the company thinking about kind of path to profitability, and when do you expect to be cash flow positive?
Sure. So, you know, with the slowdown in the market last year, we took some meaningful changes in terms of our cost base, towards the end of last year. I think you saw the benefit of that in, just even in the first quarter of this year, where our EBITDA loss improved to less than $4 million, and that was a quarter which was our lowest revenue quarter of the year. And so we're already showing that, you know, the base of expenses that we currently have for our core business is already getting towards profitability on an EBITDA basis. And we've talked about that business getting to EBITDA profitable by the end of this year, and then cash flow positive early next year.
So the base business or the core business, which is really everything outside the United States, is already well on its path to do that. When we think about the spending in the United States, which is necessary to sort of stand up that business and get it ultimately to where it is also cash flow positive, on approval, we have access to an additional $25 million of capital through our current credit facility and another $25 million that becomes available when we achieve a certain revenue milestone. So that additional $50 million that we get from the, you know, sort of pending the U.S. approval, will more than pay for what we have planned in the U.S. to get that business to cash flow breakeven.
When you think about the U.S., it's probably about a year, plus or minus, that business will be loss-making before, on an operating basis, it gets to breakeven. And so when you put those pieces together, you know, an outside the U.S. business that's already on its way to profitability and a U.S. business that will be loss-making for a year, perhaps, but then having the capital to fully fund that U.S. business with this additional debt that we can take down under our credit facility, we feel in a very good position that by, you know, the middle towards the end of next year, we should be where the entire company is breaking towards cash flow breakeven and profitability.
Great. Maybe, Juan José, how does... You know, you've been a founder of the company for almost 20 years. How does being a founder influence the way you lead the company as a CEO?
I think probably the most important thing is the pride of ownership that you bring to the company and, you know, the constant reminder of, you know, why, you know, we created the company in the first place. So I think, you know, throughout all these years, what you see at Establishment Labs is this amazing, you know, wave of innovations that have come one after the other, but what never changes is our commitment to women's health. And now, you know, we talk about that as FemTech, you know, and it's, it's kind of like women's health 2.0. It's much more advanced, and it's, the way it's, it's communicated, the narrative, I think it's, it's better for the consumer to understand. But, in general, it is that.
It is that idea that, you know, you own this business, and you have to make it, you know, happen. You know, this year is gonna be 20 years since the founding of Establishment Labs, and, it's interesting that it's kind of, like, coinciding with our process in the U.S. because that was one of our dreams right at the beginning is like, you know, can we make this a true global, you know, solution? And now it's actually happening.
An incredible journey over the last 20 years. So thinking about the forward, what is the vision for the company the next 5 years, the next 10 years? Where are we going?
I think we can be the company that elevates plastic surgery to a different level. I think plastic surgery used to be this very innovative specialty, and you know, over the last 20 years, it kind of, like, lost its humph. I think it you know, it requires technology to be able to match the you know, the creativity and the expertise of the plastic surgeons. And you know, what happened is you had these companies that you know, used to focus in plastic surgery, and then they started to give all this technology to dermatologists and medical aesthetics, and now even med spas. So the plastic surgeon has lost its edge in terms of technology, and what you see is that you know, so often it's almost like they have to you know, be creative because of the lack of technology.
And what I think we can bring to, you know, to plastic surgery is a wave of innovation so that you have technology on their side. And, already with minimally invasive, I think it shows that, you know, the market can be so much bigger. You know, already in our first group of, of Mia clinics, we're proving that there's a market expansion of 37%, and I think with time, that will increase. There are so many more opportunities in, in plastic surgery. You know, last year we gave the news that we have a program to transform gluteal aesthetics. There's about 800,000 of those procedures every year around the world with technology that is not very safe, and, you know, I think we can change that.
Beyond that, I think we have very good ideas about other things that we can do within plastic surgery that can bring a lot of value.
Great. Awesome. Maybe to wrap up, any final thoughts? You know, what excites you every day about getting up and, you know, in the position you are today, getting to be CEO of the company?
Well, I think one of the most important things for us is that, you know, we see every day, the effects of our technology in the market, and that is very rewarding. I actually make it to, you know, see surgery, every month. I see, you know, several different, procedures, when I, when I'm able to. You know, watching a breast reconstruction is amazing. Later this month, I'm in Paris because we're doing this new program about minimally invasive breast reconstruction. So those are the things that really, you know, matter because that's when we renew our commitment with technology to be transformational in every side of our business.
Great. Well, thank you both for joining us, and we really appreciate the time, and I hope everyone has a great conference. Thank you.
Thank you.
Great. Thank you.